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ACTIVE NOT RECRUITING
NCT04040764
NA

Uncemented Tritanium TKR vs Cemented Triathlon TKR

Sponsor: Royal Devon and Exeter NHS Foundation Trust

View on ClinicalTrials.gov

Summary

The Study aims to investigate whether there is a clinically important difference in peri-articular bone mineral density (BMD) and trabecular bone score (TBS) between patients undergoing two different types of knee replacement fixation - uncemented Tritanium total knee replacement (TKR) and cemented Triathlon TKR. Before undertaking a full randomised control trial however, it is necessary to establish that the proposed methodology and approach are feasible. Therefore an internal pilot study will be performed first. This registration is for the internal pilot study.

Official title: The Tritanium Uncemented Prosthesis Versus the Cemented Triathlon Prosthesis

Key Details

Gender

All

Age Range

50 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2019-10-15

Completion Date

2026-06

Last Updated

2025-02-12

Healthy Volunteers

No

Interventions

PROCEDURE

Tritanium uncemented Total Knee Replacement

This will be an internal pilot study in which patients will be blinded and randomly assigned to 1 of 2 arms with 30 patients in each arm. The first arm will receive a Triathlon knee replacement device which is cemented into place. The second arm will receive an uncemented Triathlon Tritanium TKR.

Locations (1)

Royal Devon and Exeter NHS Foundation Trust Hospital

Exeter, Devon, United Kingdom